18F-FDG Metabolism Imaging Monitoring Non-small Cell Lung Cancer Curative Effect of Chemotherapy Multicenter Clinical Study

Shanghai Jiao Tong University

Status and phase: Unknown; Phase 3

Conditions: Non-small-cell Lung Cancer

Treatments: Radiation: 18F-FDG

Study type: Interventional

Funder types: Other

Identifiers

NCT02938546

WXIE

Details and patient eligibility

About

The subject is going to use 18F-FDG PET/CT to assess different genetic NSCLC metabolism after cisplatin chemotherapy and targeted therapy, define the assessment criteria for the role of 18F-FDG PET/CT in NSCLC treatment respone and at last build multi-centre clinical trial platform of molecular classification and molecular imaging for cancer chemotherapy assessment.

Full description

Non-small-cell lung cancer (NSCLC) is the first leading cause of cancer death in the world. Systemic chemotherapy has contributed to the only choice for more than 50% NSCLC patients. The genetic abnormalities lead to different therapy response to the same chemotherapy scheme in NSCLC patients. At present, early assessment and prediction is the key for optimize NSCLC therapy. 18F-FDG PET/CT is a noninvasive cell metabolism reaction molecular imaging technology which can assess cancer glucose metabolism sensitively and react cancer proliferation to some degree. Hence 18F-FDG PET/CT may be used to assess NSCLC therapy response noninvasively. It is a reliable method to individualize NSCLC treatment clinically by define the appropriate metabolism response cut-off values and assess time points of 18F-FDG PET/CT in predicting different genetic NSCLC patients.The subject is going to use 18F-FDG PET/CT to assess different genetic NSCLC metabolism after cisplatin chemotherapy and targeted therapy, define the assessment criteria for the role of 18F-FDG PET/CT in NSCLC treatment respone and at last build multi-centre clinical trial platform of molecular classification and molecular imaging for cancer chemotherapy assessment.

Enrollment: 200 estimated patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• pathological biopsy for NSCLC; stage III-IV; plan to palliative chemotherapy (such as neoadjuvant chemotherapy, convention and targeted therapy) due to unable to surgery; not radiation therapy or chemotherapy for 6 months before enrollment; the predictive survival time more than half year;

Exclusion criteria

• with diabetes and chest radiotherapy chronic disease; brain metastases patients; with secondary primary maligmant cancer in 5 years

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Factorial Assignment

Masking: Double Blind

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200 participants in 3 patient groups

before therapy

Active Comparator group

Description:

18F-FDG PET/CT performed before therapy

Treatment:

Radiation: 18F-FDG

3 days after cisplatin chemotherapy and targeted therapy

Experimental group

Description:

18F-FDG PET/CT performed 3 days after chemotherapy and targeted therapy

Treatment:

Radiation: 18F-FDG

longer time after cisplatin chemotherapy and targeted therapy

Experimental group

Description:

18F-FDG PET/CT performed before the third cycle chemotherapy and the 7th week targeted therapy

Treatment:

Radiation: 18F-FDG